[Federal Register: February 17, 2004 (Volume 69, Number 31)]
[Notices]               
[Page 7490]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe04-95]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Ophthalmic Devices Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 5, 2004, from 9 
a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A and B, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Sara M. Thornton, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2053, ext. 127, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512396. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will discuss general issues surrounding the 
use of intraocular lenses for correction of presbyopia after clear lens 
extraction. The committee will address clinical study design elements 
including the risk/benefit ratio for patients with various refractive 
errors, study sample size, the need for control groups, inclusion/
exclusion criteria, and the incidence of retinal detachment and other 
complications. Background information, including the attendee list, 
agenda, and questions for the committee, will be available to the 
public 1 business day before the meeting, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html
.

    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by February 24, 
2004. On March 5, 2004, formal oral presentations from the public will 
be scheduled between approximately 9:15 a.m. and 9:45 a.m. Near the end 
of the committee discussion a second 30-minute open public session will 
be conducted for interested persons to comment further on the 
discussion topic. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before February 24, 2004, and submit a brief statement 
of the general nature of the evidence or arguments they wish to 
present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams at 
301-594-1283, ext. 113 at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 9, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-3334 Filed 2-13-04; 8:45 am]

BILLING CODE 4160-01-S